Inverted balloon system and inflation management system

ABSTRACT

At least one exemplary embodiment is directed to an earpiece having a balloon and a stent where the balloon is mounted on the stent and the stent incorporates two or more channels including at least an inflation channel and an acoustic channel. In some embodiments the stent is configured to pass audio signals through the acoustic channel where the acoustic channel is independent of the inflation channel of the balloon. Other embodiments are disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/578,461 filed on 13 Oct. 2009 and further claims the benefit of U.S.provisional patent application No. 61/103,923 filed 10 Oct. 2008. Thedisclosures of the aforementioned applications are incorporated hereinby reference in their entirety.

FIELD

The embodiments relate in general to pressure management and balloonbonds, and particularly though not exclusively, is related to creating apressure management system for earpiece systems.

BACKGROUND

Inflatable acoustic systems using balloons can have difficulties inmaintaining the bonding of a balloon to a stent upon insertion. Inaddition there is no pressure management system that has been designedfor an inflatable earpiece.

SUMMARY

At least one exemplary embodiment is directed to a method of invertbonding of a balloon comprising: bonding a sheath balloon to a stent ata first bond location, where the sheath balloon has first surface and asecond surface, where the bonding at the first bond location is betweenthe stent and a portion of the first surface, where the first surfacefaces the stent; pulling the sheath balloon from an unbounded end overthe first bond to a chosen second bond location so that the firstsurface faces away from the stent forming an inverted bond at the firstbond location; and bonding the sheath at the second bond location wherethe bonding at the second bond location is between the stent and aportion of the second surface.

At least one exemplary embodiment is directed to a method of forming aninverted bond balloon comprising: aligning a mold core with a first anda second mold shell, where the first shell has an injection port, wherethe first and second mold shell and the mold core are aligned usingalignment recesses and pins, where when the mold core is aligned thereis a gap between a portion of the mold core and the first and secondmold shells, where the gap is designed to be related to a molded balloonthickness; aligning the injection port with an injection nozzle;clamping a mold against an injection nozzle; inserting a flexiblematerial into the mold through the injection port of the mold; removingthe mold from the injection nozzle; curing the material in the mold,where curing can be at least one of cooling, UV illumination, andchemical reaction; and opening the mold and removing a molded balloonwith at least one inverted bond, where the molded balloon is configuredso that when attached to a stent and inflated the inverted bond pressesagainst a stent.

At least one exemplary embodiment is directed to an inverted bondballoon stent comprising: a balloon bonded to a stent, where the balloonhas at least one end of the balloon inverted bonded to the stent; and astent, where the stent is configured to provide one of air and liquid tothe balloon.

At least one exemplary embodiment is directed to a pressure managementsystem for an earpiece comprising: a first valve, where the first valveallows air to pass from a first side of the valve to a second side morereadily than from the second side to the first side; an inflationchannel, where the inflation channel has an outer diameter less than 5mm; a pressure release mechanism; a pump; a stent, where the inflationchannel is embedded; and a balloon, where the first valve, the inflationchannel, the pressure release mechanism, the pump, and the balloon areoperatively connected, where the first valve is positioned so that airfrom the pump passes through the first valve to inflate the balloon andwhere the leak rate of the air from the balloon back to the pump is lessthan 1% by volume per minute and where the pressure release mechanism isconfigured to release pressure from the balloon to the environment uponactuation, and where the pressure management system is configured tomanage the inflation pressure of the balloon in an orifice.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments herein will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIGS. 1 through 4 illustrate a method of bonding a balloon sheath to astent to form an inverted bond in accordance with at least one exemplaryembodiment;

FIG. 5 illustrates an inflated balloon having an inverted bond inaccordance with at least one exemplary embodiment.

FIG. 6 illustrates the restoring force associated with an inverted bondof a balloon in accordance with at least one exemplary embodiment;

FIG. 7 illustrates a core mold associated with the molding of a balloonwith an inverted bond in accordance with at least one exemplaryembodiment;

FIG. 8 illustrates the core mold inserted into one shell mold inaccordance with at least one exemplary embodiment;

FIG. 9 illustrates a core mold inserted into two shell molds inaccordance with at least one exemplary embodiment;

FIG. 10 illustrates a pressure management system also referred to as aninflation management system (IMS) in accordance with at least oneexemplary embodiment;

FIG. 11 illustrates a block diagram of an IMS system using a manual pumpin accordance with at least one exemplary embodiment;

FIG. 12 illustrates a block diagram of an IMS system using a automatedpump in accordance with at least one exemplary embodiment; and

FIG. 13 illustrates a diagram of an restoring membrane based IMS inaccordance with at least one exemplary embodiment.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The following description of exemplary embodiment(s) is merelyillustrative in nature and is in no way intended to limit the invention,its application, or uses.

Processes, techniques, apparatus, and materials as known by one ofordinary skill in the art may not be discussed in detail but areintended to be part of the enabling description where appropriate. Forexample specific computer code may not be listed for achieving each ofthe steps discussed, however one of ordinary skill would be able,without undo experimentation, to write such code given the enablingdisclosure herein. Such code is intended to fall within the scope of atleast one exemplary embodiment.

Additionally, the sizes of structures used in exemplary embodiments arenot limited by any discussion herein (e.g., the sizes of structures canbe macro (centimeter, meter, and size), micro (micro meter), nanometersize and smaller).

Notice that similar reference numerals and letters refer to similaritems in the following figures, and thus once an item is defined in onefigure, it may not be discussed or further defined in the followingfigures.

In all of the examples illustrated and discussed herein, any specificvalues, should be interpreted to be illustrative only and non-limiting.Thus, other examples of the exemplary embodiments could have differentvalues.

Additionally various materials can be used for inflations channels,stents, acoustic channels, valves, balloons and pressure releasemechanism. For example for examples for the stent, valves, inflationchannels, and balloons a material that has a low permeability to themedium in the balloon can be used. For example Teflon can be used for anair medium. The type of material will be governed by the designcriteria. For example a flexible material that has an air permeabilityof less than 5% loss of volume in 6 hours is SARLINK™.

FIGS. 1 through 4 illustrate a method of bonding a balloon sheath to astent to form an inverted bond in accordance with at least one exemplaryembodiment. At least one exemplary embodiment is directed to a method ofinvert bonding of a balloon comprising: bonding a sheath balloon 110(e.g., of SARLINK™ or other materials that have a low permeability tothe medium (air and liquid) in the balloon) to a stent (e.g., which canbe made of the same material as the balloon and which can also have alow permeability (e.g., loss of medium by volume is less than 3% in a 16hour period) at a first bond location 120 (e.g., at the stent tip andextending inward a distance for example about 1 mm), where the sheathballoon has first surface and a second surface, where the bonding (e.g.,adhesive bonding, thermal bonding, UV curing bonding, or molding theballoon and stent as one piece) at the first bond location is betweenthe stent and a portion of the first surface, where the first surfacefaces the stent (FIGS. 1 and 2, where the stent 100 can have an acousticchannel 105); pulling (e.g., pulling from A in the direction of 130) thesheath balloon from an unbounded end over the first bond (from A to B,FIGS. 3 and 4) to a chosen second bond location (B) (FIG. 3) so that thefirst surface faces away from the stent forming an inverted bond at thefirst bond location; and bonding the sheath at the second bond locationwhere the bonding (170, FIG. 5) at the second bond location is betweenthe stent and a portion of the second surface.

Note the bond strengths are such that various balloon pressures can bemaintained. For example an internal gauge pressure between 0.05 bar to 3bar. FIG. 5 illustrates an inflated balloon 120, expanded in accordanceto at least one exemplary embodiment. Note that the tip is nearlyobscured (the forward portion of the inflated balloon can vary inlength, it can extent completely over (e.g. align with the tip or extentover several mms) the tip (through which 105 is shown) to recessed(e.g., 1 mm from the tip) in the radial direction from the expandingballoon.

FIG. 6 illustrates how an inflated balloon with an inverted bond has thepressure presses the bond (e.g., 620) to the stent rather than try andseparate the balloon from the stent as the exterior pressure (610) woulddo if there were not an inverted bond. This allows some force to beexerted along and/or radial to the stent on the balloon 120. Note inFIG. 6 only one inverted bond is shown (e.g., bond 170 is not aninverted bond), however at least one exemplary embodiment has bond 170also replaced with an inverted bond, in such a situation the sheathwould be moved from B to A slightly and the B end flipped to form aninverted bond.

In addition to bonding a sheath balloon on a stent to form an invertedbond, an inverted bond can be molded (see FIGS. 7, 8, and 9).

FIGS. 7, 8, and 9 illustrate a mold that can be used in a method offorming an inverted bond balloon. For example at least one exemplaryembodiment if directed to a method of molding a balloon with an invertedbond comprising: aligning a mold core with a first and a second moldshell (750, 790), where the first shell has an injection port (760),where the first and second mold shell and the mold core are alignedusing alignment recesses (710, 720) and pins (710A, 720A), where whenthe mold core is aligned there is a gap between a portion of the moldcore and the first and second mold shells, where the gap (730) isdesigned to be related to a molded balloon thickness (e.g., 0.1 mm);aligning the injection port 760 with an injection nozzle; clamping amold against an injection nozzle; inserting a flexible material into themold through the injection port of the mold; removing the mold from theinjection nozzle; curing the material in the mold, where curing can beat least one of cooling, UV illumination, and chemical reaction; andopening the mold and removing a molded balloon with at least oneinverted bond, where the molded balloon is configured so that whenattached to a stent and inflated the inverted bond presses against astent.

Note that the gap 730 can be variable throughout the mold allowing oneto mold variable thickness balloons. For example a region of the balloonthat one would want to expand first can be thinner than another part ofthe balloon. Note that the material that can be used for molding can(besides satisfying the design permeability requirement set duringdesign) be flexible. Note that the flexible material can have a linearelongation of greater than 100% without deformation of more than 5% inthe area of the balloon when deflated. Some sample materials areSARLINK™.

Note that the stent can be connected to microphones, where some cansample the ambient environment (ASM 1150), some sampling the ear canal(ECM, 1170) and receivers, some playing acoustic energy into the earcanal (ECR 1160). Note various microphones and receivers can be used,for example Knowles MEM microphones, TO and FG microphones, and TWFKreceivers.

FIGS. 10 through 13 illustrate inflation management systems (alsoreferred to as pressure management systems) in accordance with at leasta few exemplary embodiments. For example at least one exemplaryembodiment is directed to a pressure management system (e.g., 1090,1100, 1200) for an earpiece (e.g., a device that is designed to be usedwith any part of the ear) comprising: a first valve (e.g., duck valves,one way valves, . . . 1030, 1130A-1130F), where the first valve allowsair to pass from a first side of the valve to a second side more readilythan from the second side to the first side; an inflation channel, wherethe inflation channel has an outer diameter less than the size of anorifice in which it is to be inserted (e.g., <5 mm); a pressure releasemechanism (e.g., a pin to push open the valve 1030); a pump (e.g., amanual pump (e.g., bladder), automatic pump (e.g., linear actuator) astent, where the inflation channel is embedded; and a balloon, where thefirst valve, the inflation channel, the pressure release mechanism, thepump, and the balloon are operatively connected, where the first valveis positioned so that air from the pump passes through the first valveto inflate the balloon and where the leak rate of the air from theballoon back to the pump is less than 1% by volume per minute and wherethe pressure release mechanism is configured to release pressure fromthe balloon to the environment upon actuation, and where the pressuremanagement system is configured to manage the inflation pressure of theballoon in an orifice.

Note that the stent can be as large as the inflation tube or larger.

Note that at least one exemplary embodiment can include a second valveto release pressure when the pressure in the balloon exceeds a designthreshold (e.g., between 0.05 bar gauge to 3 bar gauge).

Note also that FIGS. 11 and 12 illustrate detachable stents and balloonsystems (ear manifold 1120) from eth remaining elements (instrumentpackage 1111). A valve in the stent 1130C can allow the one way passageof medium into the balloon (e.g., inflation element 1180). A secondvalve 1130D can release pressure if it gets above a certain value. Forexample if the gauge pressure exceeds 0.25 bar gauge. Note that the pumpcan also be connected to a release valve 1130F. For an automated pump apower source 1210 (e.g. battery) can power the pump 1130.

FIG. 13 illustrates a restoring membrane exemplary embodiment, where aninflated balloon 1330, when pressed (e.g., via ear canal wall) exertspressure on a restoring membrane 1320. The restoring membrane canprovide a restoring force 1310A, which is felt by the balloon 1310B sothat when the balloon is no longer pressed it will expand back to anequilibrium position. The restoring membrane can be one that has ahigher elastic elongation than the balloon material, or be thinner. Therestoring membrane and balloon can be pneumatically coupled 1350 throughthe stent 100.

Note that an earpiece can include an Ambient Sound Microphone (ASM) tocapture ambient sound, an Ear Canal Receiver (ECR) to deliver audio toan ear canal and an Ear Canal Microphone (ECM) to capture and assess asound exposure level within the ear canal. The earpiece can partially orfully occlude the ear canal to provide various degrees of acousticisolation. In at least one exemplary embodiment, assembly is designed tobe inserted into the user's ear canal, and to form an acoustic seal withthe walls of the ear canal at a location between the entrance to the earcanal and the tympanic membrane (or ear drum). In general, such a sealis typically achieved by means of the balloon.

While the present invention has been described with reference toexemplary embodiments, it is to be understood that the invention is notlimited to the disclosed exemplary embodiments. The scope of thefollowing claims is to be accorded the broadest interpretation so as toencompass all such modifications and equivalent structures andfunctions.

What is claimed is:
 1. An earpiece, comprising: a balloon; and a stent, wherein the balloon is mounted on the stent and the stent incorporates two or more channels including at least an inflation channel and an acoustic channel, where the stent is configured to pass audio signals through the acoustic channel that is independent of the inflation channel of the balloon.
 2. The earpiece of claim 1, wherein the acoustic channel is coupled to at least one of a microphone or a receiver at one end of the acoustic channel.
 3. The earpiece of claim 1, wherein the stent is configured to provide or carry one of air or liquid to and from the balloon.
 4. The earpiece according to claim 1, where the stent is configured to provide or carry air or fluids to and from the balloon via the inflation channel that is pneumatically coupled to the balloon.
 5. The earpiece according to claim 1, wherein the acoustic channel is connected at one end to a microphone.
 6. The earpiece according to claim 1, wherein the acoustic channel is connected at one end to a receiver.
 7. The earpiece of claim 1, wherein the stent passes through the balloon.
 8. The earpiece according to claim 1, wherein the balloon comprises a sheath balloon having a first surface and a second surface, wherein a bond exists at a first bond location between the stent and a portion of the first surface, where the first surface faces the stent and wherein the sheath balloon is pulled from an unbounded end over the first bond to a chosen second bond location so that the first surface faces away from the stent forming an inverted bond at the first bond location, and a second bond location where a bonding at the second bond location is between the stent and a portion of the second surface.
 9. The earpiece according to claim 1, further comprising a pressure management system for the earpiece.
 10. The earpiece according to claim 9, wherein the pressure management system comprises: a first valve, where the first valve allows air to pass from a first side of the valve to a second side more readily than from the second side to the first side; the inflation channel, wherein the inflation channel is embedded; and the balloon.
 11. The earpiece according to claim 10, wherein the pressure management system further comprises a pressure release mechanism, a pump, and the stent.
 12. The earpiece of claim 10, wherein the first valve, the inflation channel, the pressure release mechanism, the pump, and the balloon are operatively connected, where the first valve is positioned so that air from the pump passes through the first valve to inflate the balloon.
 13. The earpiece of claim 12, where the leak rate of the air from the balloon back to the pump is less than 1% by volume per minute and where the pressure release mechanism is configured to release pressure from the balloon to the environment upon actuation, and where the pressure management system is configured to manage the inflation pressure of the balloon in an orifice.
 14. The pressure management system according to claim 13, where the inflation channel is in the stent, inflation channel inner diameter is less than 2 mm, and where the stent outer diameter is less than about 4 mm.
 15. The pressure management system according to claim 14, further comprising a second valve, where the second valve is configured to release pressure when the balloon pressure exceeds a threshold pressure value.
 16. The pressure management system according to claim 15, where the threshold value is in the range of about 0.15 bar gauge pressure to 0.30 bar gauge pressure.
 17. The pressure management system according to claim 11, where the pump is at least one of a manual pump and an automatic pump.
 18. The pressure management system according to claim 10, where the stent and balloon are detachable from the remaining elements of the pressure management system.
 19. The pressure management system according to claim 15, where the pressure in the balloon upon detachment maintains its pressure by use of at least a third valve operatively connected to the stent.
 20. A closed pressure management system, comprising: a balloon; a restoring membrane; and a stent having an inflation channel of the balloon and an acoustic channel, where the stent is configured to pass audio signals through the acoustic channel that is independent of the inflation channel of the balloon and where the balloon and restoring membrane are pneumatically coupled so that when the balloon is inflated and depressed the restoring membrane will expand supplying a restoring force to counter the depression, and where the balloon, stent and restoring membrane are operatively and pneumatically coupled in a closed system. 